EP4233730A2 - Non-invasive device for detecting liver damage - Google Patents

Non-invasive device for detecting liver damage Download PDF

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Publication number
EP4233730A2
EP4233730A2 EP23172405.5A EP23172405A EP4233730A2 EP 4233730 A2 EP4233730 A2 EP 4233730A2 EP 23172405 A EP23172405 A EP 23172405A EP 4233730 A2 EP4233730 A2 EP 4233730A2
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EP
European Patent Office
Prior art keywords
score
constructed
hepatic
parameter correlated
parameter
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EP23172405.5A
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German (de)
French (fr)
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EP4233730A3 (en
Inventor
Véronique Miette
Laurent Sandrin
Magali Sasso
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Echosens SA
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Echosens SA
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/42—Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems
    • A61B5/4222—Evaluating particular parts, e.g. particular organs
    • A61B5/4244—Evaluating particular parts, e.g. particular organs liver
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4842—Monitoring progression or stage of a disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235—Details of waveform analysis
    • A61B5/7264—Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271—Specific aspects of physiological measurement analysis
    • A61B5/7275—Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/48—Diagnostic techniques
    • A61B8/485—Diagnostic techniques involving measuring strain or elastic properties
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/52—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/5215—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data
    • A61B8/5223—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data for extracting a diagnostic or physiological parameter from medical diagnostic data
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/30—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indices; for individual health risk assessment

Definitions

  • the invention relates to a non-invasive device for detecting liver damage using ultrasonic waves and shear waves.
  • This device can be used for humans and for animals and is for example intended for the detection of a hepatic lesion of the steatohepatitis type of alcoholic origin (also known by the acronym ASH for Alcoholic SteatoHepatitis in English) or non-alcoholic (also known by the acronym NASH for Non Alcoholic Steato Hepatitis in English).
  • the invention also relates to a score reflecting liver damage.
  • liver tissue diseases generate liver damage such as fibrosis.
  • Fibrosis is a fibrous scarring process of liver tissue resulting from inflammation.
  • the evolution of initially asymptomatic fibrosis can progress to cirrhosis.
  • the elasticity of liver tissue is a marker of liver fibrosis.
  • impulse elastography as described, for example, in patent application number EN 2843290 .
  • This document presents an implementation of a device according to the prior art.
  • This device is composed of a probe provided with a vibration generator generating a low frequency elastic wave in a tissue, for example by vibration, and analyzing the propagation of this low frequency elastic wave using high frequency ultrasonic waves. transmitted and received by an ultrasonic transducer. The measurements obtained via this device make it possible to quantify the elasticity of the hepatic tissue.
  • This device also makes it possible to quantify the ultrasonic attenuation of tissues, as described, for example, in patent application number EN 2949965 . Quantification of ultrasound attenuation in the liver correlates with the amount of steatosis.
  • NASH Newcastle disease senor
  • certain diseases for example NASH, are not necessarily linked only to the quantity of fibrosis or the quantity of steatosis alone, and may, for example, associate steatosis-type lesions (presence of fatty in the liver) and inflammation with or without fibrosis. Therefore, NASH stage or progression to NASH cannot be diagnosed by a single parameter.
  • the present invention aims to solve at least one of the aforementioned drawbacks of the state of the art.
  • the invention proposes a non-invasive device for detecting liver damage taking into account various parameters.
  • the invention also provides a score reflecting a type of hepatic lesion.
  • This embodiment has in particular the advantage of allowing early detection of certain types of hepatic lesion, such as for example NASH, NASH possibly being correlated with inflammation, fibrosis and steatosis.
  • NAFLD for Non-Alcoholic Fatty Liver Disease
  • the score is a quantitative or semi-quantitative evaluation (for example, binary indicator) of a hepatic lesion of the steatohepatitis type of alcoholic or non-alcoholic origin.
  • the device according to the invention is constructed and arranged to deliver the score concomitantly with the physical parameters measured.
  • the echograph or the device constructed and arranged to measure at least the hepatic elasticity measures physical parameters and the device according to the invention calculates the score by taking into account at least the physical parameters measured.
  • the parameter correlated with fibrosis is elasticity.
  • the parameter correlated with the steatosis is a measurement of the attenuation of the ultrasonic waves, for example the parameter called CAP as described in the article Sasso, M., et al. (2010).
  • Controlled attenuation parameter (CAP) a novel VCTE guided ultrasonic attenuation measurement for the evaluation of hepatic steatosis: preliminary study and validation in a cohort of patients with chronic liver disease from various causes.”
  • the parameter correlated with the steatosis is a measurement of viscosity of the hepatic tissue.
  • the calculation device is constructed and arranged to calculate a score by means of at least one additional parameter correlated with the inflammatory activity.
  • this parameter can be the value of transaminases, ALAT, ASAT, GGT, hepatic elasticity or hepatic viscosity.
  • the calculation device is constructed and arranged to calculate a score by means of at least one additional parameter correlated with the metabolic syndrome.
  • the calculation device is constructed and arranged to calculate a score by means of at least one additional parameter of the anthropomorphic type.
  • the calculation device is constructed and arranged to calculate a score by means of at least one additional parameter of biological type.
  • the at least one biological parameter can for example be chosen from the following parameters: transaminases (ASAT, ALAT), GGT, ALP, serum iron, ferritin, transferrin saturation, adipokine (for example, adiponectin, leptin, resistin), cytokine (e.g., TNF ⁇ , IL6, IL1- ⁇ ), HDL cholesterol, blood glucose, insulinaemia, bilirubin, a2macroglobulin, haptoglobin, apolipoprotein A1, CK18, triglycerides, adiponectin, urea, genetic polymorphism (e.g. PNPLA3 polymorphism, TM6SF2), CRP and / or leptin.
  • ASAT transaminases
  • ALAT ALAT
  • GGT GGT
  • ALP serum iron
  • ferritin ferritin
  • the calculation device is constructed and arranged to communicate with a score display device.
  • the score can be displayed as a numerical value, a binary indicator, a probability or a risk.
  • This embodiment has in particular the advantage of allowing simplicity of interpretation of the analysis of the score reflecting a state of a calculated hepatic connection.
  • the score takes into account at least one inflammatory activity parameter.
  • the at least one activity parameter inflammation can be chosen from the following parameters: the value of transaminases, hepatic elasticity or hepatic viscosity.
  • the score takes into account at least one anthropomorphic parameter of the weight, height, waist circumference, hip circumference, thoracic perimeter or demographic parameter of the age and sex type.
  • the score takes into account at least a biological parameter.
  • the at least one biological parameter can be chosen from the following parameters: transaminases (ASAT, ALAT), GGT, ALP, serum iron, ferritin, transferrin saturation, adipokine (for example, adiponectin, leptin, resistin) cytokine (for example, TNF ⁇ , IL6, IL1- ⁇ ), cholesterol, HDL cholesterol, blood glucose, insulin, bilirubin, a2macroglobulin, haptoglobin, apolipoprotein A1, CK18, triglycerides, adiponectin, urea, genetic polymorphism (e.g. PNPLA3 polymorphism, TM6SF2), CRP and/ or leptin.
  • ASAT transaminases
  • ALAT ALAT
  • GGT GGT
  • ALP serum iron
  • ferritin ferritin
  • transferrin saturation for example, adipokine (for example, adiponectin, leptin, resistin
  • the biological parameter can be a metabolomic parameter.
  • the score is calculated using statistical modeling (also called statistical learning) of the logistic regression type, decision trees, Bayesian classifier, random forests, SVM, neural network, discriminant analysis, etc. .
  • FIG. 1 represents a device 100 for calculating a score reflecting a state of hepatic damage integrated into a device 200 constructed and arranged to measure hepatic elasticity.
  • the device 200 comprises an elastography probe 201 equipped with an ultrasonic transducer 202 built and arranged to emit and receive ultrasonic waves.
  • the elastography probe 201 further comprises means for generating a shear wave in the hepatic tissue.
  • Said means can be an electrodynamic actuator 203 constructed and arranged to generate a low frequency wave.
  • the device 200 is therefore constructed and arranged to measure physical parameters, for example parameters which are correlated with inflammation and/or fibrosis and parameters which are correlated with steatosis.
  • a parameter linked to fibrosis can be the elasticity of the liver. This measure of elasticity constitutes a marker of the pathological state of the liver tissue.
  • the parameter correlated with steatosis may be a measure of attenuation of ultrasound waves in liver tissue.
  • Fatty liver disease is an accumulation of fat in the liver. The measurement of the attenuation of the propagation of ultrasonic waves therefore makes it possible to quantify the steatosis.
  • the device 100 for calculating a score reflecting a state of liver damage is constructed and arranged to calculate a score by means of a parameter correlated to the inflammation of the hepatic tissue and/or a parameter correlated to the fibrosis. In the example described, these parameters are measured by means of the elastography probe 201.
  • the device 200 also comprises a man-machine interface 204 built and arranged to enter marker parameters of the metabolic syndrome used for the calculation of the score.
  • Metabolic syndrome means the association of a series of health problems having in common a poor body metabolism, it is a group of risk factors more or less linked by an origin, metabolic targets or common mechanisms. This group of parameters may thus include: HDL cholesterol, triglycerides, glycaemia, blood pressure, and/or waist circumference.
  • This man-machine interface 204 is also constructed and arranged to enter biological parameters used for calculating the score. These biological parameters can be: transaminases (ALT, AST), GGT, PAL, serum iron, cholesterol, HDL cholesterol, glycaemia, insulinaemia, bilirubin, a2macroglobulin, haptoglobin, apolipoprotein A1, CK18, triglycerides, adiponectin, and/or leptin.
  • transaminases ALT, AST
  • GGT GGT
  • PAL PAL
  • serum iron cholesterol
  • HDL cholesterol glycaemia
  • insulinaemia insulinaemia
  • bilirubin a2macroglobulin
  • haptoglobin apolipoprotein A1
  • CK18 triglycerides
  • adiponectin adiponectin
  • This man-machine interface 204 is also constructed and arranged to enter anthropomorphic and demographic parameters used for calculating the score. These demographic and anthropomorphic parameters are for example formed by the age, sex, height, weight, waist circumference, hip circumference or chest circumference of a person.
  • the calculation device 100 calculates a score by means of a logistic regression or any other scoring method, for example of the decision tree type, Bayesian classifier, random forests, large margin separator decision trees (SVM), or neural network.
  • a logistic regression or any other scoring method for example of the decision tree type, Bayesian classifier, random forests, large margin separator decision trees (SVM), or neural network.
  • the calculation device 100 can be formed by one or more microprocessors constructed and adapted to execute sequences of instructions allowing implementation of the aforementioned logistic regression or any other scoring method.
  • the calculated score is represented in the form of a binary indicator 205 equal to 1 and displayed on a screen 206 of the device 200.
  • This binary indicator 205 can be used to recommend that a patient carry out a consultation with from a specialist. For example, when the indicator is equal to 1, the patient is diagnosed as being at risk and requires further investigation or additional tests must be performed.
  • the indicator when the indicator is equal to 0, the patient should not consult a specialist.
  • This indicator can also be different, it can be implemented as a value.
  • the measurements of physical parameters, the entry of other parameters, the calculation of the score and the display of the score are carried out on the device 200.
  • this embodiment has in particular the advantage of calculating in real time the score (in other words on the place where the measurements of the physical parameters are carried out), then to display the score thus allowing a speed of analysis.
  • the device 200 can be formed by an ultrasound scanner, an MRI, or an MRI implementing magnetic resonance elastography (MRE).
  • MRE magnetic resonance elastography
  • the device for calculating a score reflecting a state of liver damage 100 is constructed and arranged to communicate with a remote ultrasound scanner 300 .
  • the computing device 100 is remote from the ultrasound scanner 300.
  • the measurements are made on the ultrasound scanner 300 then transmitted by a network link 140, for example an Ethernet or Bluetooth type link. or Wi-Fi, to the computing device 100.
  • a network link 140 for example an Ethernet or Bluetooth type link. or Wi-Fi
  • this computer 400 can communicate with the computing device 100 via an Ethernet or Wi-Fi link 150.
  • the computing device 100 can be materialized by one or more processors.
  • the computer can be integrated into the 300 ultrasound system.
  • the display of the score can be carried out on the echograph 300, on the computer 400 or both.

Abstract

L'invention porte notamment sur un dispositif de calcul (100) d'un score (205) reflétant un état d'une lésion hépatique, ledit dispositif de calcul (100) étant construit et agencé pour calculer un score (205) au moyen des paramètres physiques suivants :- Un paramètre corrélé à l'inflammation et/ou à la fibrose,- Un paramètre corrélé à la stéatose.The invention relates in particular to a device (100) for calculating a score (205) reflecting a state of liver damage, said calculating device (100) being constructed and arranged to calculate a score (205) by means of the following physical parameters: - A parameter correlated with inflammation and/or fibrosis, - A parameter correlated with steatosis.

Description

DOMAINE TECHNIQUETECHNICAL AREA

L'invention concerne un dispositif non invasif de détection de lésion hépatique utilisant les ondes ultrasonores et les ondes de cisaillement. Ce dispositif peut être utilisé pour l'homme et pour l'animal et est par exemple destiné à la détection d'une lésion hépatique de type stéato-hépatite d'origine alcoolique (également connue sous l'acronyme ASH pour Alcoholic SteatoHepatitis en anglais) ou non alcoolique (également connue sous l'acronyme NASH pour Non Alcoholic Steato Hepatitis en anglais). L'invention se rapporte également à un score reflétant une lésion hépatique.The invention relates to a non-invasive device for detecting liver damage using ultrasonic waves and shear waves. This device can be used for humans and for animals and is for example intended for the detection of a hepatic lesion of the steatohepatitis type of alcoholic origin (also known by the acronym ASH for Alcoholic SteatoHepatitis in English) or non-alcoholic (also known by the acronym NASH for Non Alcoholic Steato Hepatitis in English). The invention also relates to a score reflecting liver damage.

ART ANTERIEURPRIOR ART

Habituellement, les maladies chroniques du tissu hépatique génèrent des lésions hépatiques telles que la fibrose. La fibrose est un processus de cicatrisation fibreux du tissu hépatique résultant d'une inflammation. L'évolution de la fibrose initialement asymptomatique peut évoluer vers une cirrhose. L'élasticité du tissu hépatique constitue un marqueur de la fibrose hépatique. Afin de mesurer et quantifier l'élasticité du tissu hépatique, il est connu d'utiliser l'élastographie impulsionnelle, comme décrit, par exemple, dans la demande de brevet numéro FR 2843290 .Usually, chronic liver tissue diseases generate liver damage such as fibrosis. Fibrosis is a fibrous scarring process of liver tissue resulting from inflammation. The evolution of initially asymptomatic fibrosis can progress to cirrhosis. The elasticity of liver tissue is a marker of liver fibrosis. In order to measure and quantify the elasticity of hepatic tissue, it is known to use impulse elastography, as described, for example, in patent application number EN 2843290 .

Ce document présente une mise en oeuvre d'un dispositif selon l'art antérieur. Ce dispositif est composé d'une sonde munie d'un générateur de vibration générant une onde élastique basse fréquence dans un tissu, par exemple par vibration, et analysant la propagation de cette onde élastique basse fréquence à l'aide d'ondes ultrasonores haute fréquence émises et reçues par un transducteur ultrasonore. Les mesures obtenues via ce dispositif permettent de quantifier l'élasticité du tissu hépatique. Ce dispositif permet également de quantifier l'atténuation ultrasonore des tissus, comme décrit, par exemple, dans la demande de brevet numéro FR 2949965 . La quantification de l'atténuation ultrasonore dans le foie est corrélée la quantité de stéatose.This document presents an implementation of a device according to the prior art. This device is composed of a probe provided with a vibration generator generating a low frequency elastic wave in a tissue, for example by vibration, and analyzing the propagation of this low frequency elastic wave using high frequency ultrasonic waves. transmitted and received by an ultrasonic transducer. The measurements obtained via this device make it possible to quantify the elasticity of the hepatic tissue. This device also makes it possible to quantify the ultrasonic attenuation of tissues, as described, for example, in patent application number EN 2949965 . Quantification of ultrasound attenuation in the liver correlates with the amount of steatosis.

En revanche, chez l'homme certaines maladies, par exemple la NASH, ne sont pas nécessairement liées qu'à la seule quantité de fibrose ou à la seule quantité de stéatose, et peut par exemple associer des lésions de type stéatose (présence de graisse dans le foie) et inflammation avec ou sans fibrose. Par conséquent, le stade de NASH ou l'évolution vers la NASH ne peut pas être diagnostiqué au moyen d'un seul paramètre.On the other hand, in humans, certain diseases, for example NASH, are not necessarily linked only to the quantity of fibrosis or the quantity of steatosis alone, and may, for example, associate steatosis-type lesions (presence of fatty in the liver) and inflammation with or without fibrosis. Therefore, NASH stage or progression to NASH cannot be diagnosed by a single parameter.

EXPOSE DE L'INVENTIONDISCLOSURE OF THE INVENTION

La présente invention vise à résoudre au moins un des inconvénients de l'état de la technique précités. Pour cela, l'invention propose un dispositif non invasif de détection de lésion hépatique prenant en compte différents paramètres. L'invention propose également un score reflétant un type de lésion hépatique.The present invention aims to solve at least one of the aforementioned drawbacks of the state of the art. For this, the invention proposes a non-invasive device for detecting liver damage taking into account various parameters. The invention also provides a score reflecting a type of hepatic lesion.

A cette fin, un aspect de l'invention a pour objet un dispositif de calcul d'un score pour l'homme ou l'animal ledit score étant une évaluation quantitative ou semi-quantitative d'une lésion hépatique de type stéato-hépatite d'origine alcoolique ou non-alcoolique, ledit dispositif de calcul étant construit et agencé pour calculer un score au moyen des paramètres au moins physiques voire biologiques suivants :

  • Un paramètre corrélé à l'inflammation et/ou à la fibrose,
  • Un paramètre corrélé à la stéatose.
To this end, one aspect of the invention relates to a device for calculating a score for humans or animals, said score being a quantitative or semi-quantitative evaluation of a hepatic lesion of the steatohepatitis d type. of alcoholic or non-alcoholic origin, said calculating device being constructed and arranged to calculate a score by means of the following at least physical or even biological parameters:
  • A parameter correlated with inflammation and/or fibrosis,
  • A parameter correlated with steatosis.

Ce mode de réalisation présente notamment l'avantage de permettre une détection précoce de certains types de lésion hépatique, comme par exemple la NASH, la NASH pouvant être corrélée à une inflammation, à une fibrose et à une stéatose. En revanche, la NAFLD (pour Non-Alcoholic Fatty Liver Disease) est corrélée simplement à la stéatose. Grâce au score, il est donc possible de différencier des patients atteints d'une maladie de type NAFLD des patients atteints d'une maladie de type NASH.This embodiment has in particular the advantage of allowing early detection of certain types of hepatic lesion, such as for example NASH, NASH possibly being correlated with inflammation, fibrosis and steatosis. On the other hand, NAFLD (for Non-Alcoholic Fatty Liver Disease) is simply correlated with steatosis. Thanks to the score, it is therefore possible to differentiate patients suffering from a disease of the NAFLD type from patients suffering from a disease of the NASH type.

Dans une mise en oeuvre non limitative du dispositif selon l'invention, le score est une évaluation quantitative ou semi-quantitative (par exemple, indicateur binaire) d'une lésion hépatique de type stéato-hépatite d'origine alcoolique ou non alcoolique.In a non-limiting implementation of the device according to the invention, the score is a quantitative or semi-quantitative evaluation (for example, binary indicator) of a hepatic lesion of the steatohepatitis type of alcoholic or non-alcoholic origin.

Dans une mise en oeuvre non limitative du dispositif de calcul selon l'invention, le dispositif de calcul est embarqué dans :

  • un échographe, ou
  • un dispositif construit et agencé pour mesurer au moins l'élasticité hépatique.
In a non-limiting implementation of the computing device according to the invention, the computing device is embedded in:
  • an ultrasound machine, or
  • a device constructed and arranged to measure at least hepatic stiffness.

Dans une mise en oeuvre non limitative, le dispositif selon l'invention est construit et agencé pour délivrer le score de manière concomitante aux paramètres physiques mesurés. En d'autres termes, l'échographe ou le dispositif construit et agencé pour mesurer au moins l'élasticité hépatique mesure des paramètres physiques et le dispositif selon l'invention calcule le score en prenant compte au moins des paramètres physiques mesurés.In a non-limiting implementation, the device according to the invention is constructed and arranged to deliver the score concomitantly with the physical parameters measured. In other words, the echograph or the device constructed and arranged to measure at least the hepatic elasticity measures physical parameters and the device according to the invention calculates the score by taking into account at least the physical parameters measured.

Dans une mise en oeuvre non limitative du dispositif de calcul selon l'invention, le dispositif de calcul est construit et agencé pour communiquer avec :

  • un échographe distant, ou
  • un dispositif distant construit et agencé pour mesurer au moins l'élasticité hépatique.
In a non-limiting implementation of the computing device according to the invention, the computing device is built and arranged to communicate with:
  • a remote ultrasound system, or
  • a remote device constructed and arranged to measure at least hepatic stiffness.

Dans une mise en oeuvre non limitative du dispositif selon l'invention, le paramètre corrélé à la fibrose est l'élasticité.In a non-limiting implementation of the device according to the invention, the parameter correlated with fibrosis is elasticity.

Dans une mise en oeuvre non limitative du dispositif selon l'invention, le paramètre corrélé à la stéatose est une mesure de l'atténuation des ondes ultrasonores, par exemple le paramètre appelé CAP tel que décrit dans l'article Sasso, M., et al. (2010). "Controlled atténuation parameter (CAP): a novel VCTE guided ultrasonic atténuation measurement for the évaluation of hepatic steatosis: preliminary study and validation in a cohort of patients with chronic liver disease from various causes." Ultrasound Med Biol 36(11): 1825-1835 .In a non-limiting implementation of the device according to the invention, the parameter correlated with the steatosis is a measurement of the attenuation of the ultrasonic waves, for example the parameter called CAP as described in the article Sasso, M., et al. (2010). "Controlled attenuation parameter (CAP): a novel VCTE guided ultrasonic attenuation measurement for the evaluation of hepatic steatosis: preliminary study and validation in a cohort of patients with chronic liver disease from various causes." Ultrasound Med Biol 36(11): 1825-1835 .

Dans une mise en oeuvre non limitative du dispositif selon l'invention, le paramètre corrélé à la stéatose est une mesure de viscosité du tissu hépatique.In a non-limiting implementation of the device according to the invention, the parameter correlated with the steatosis is a measurement of viscosity of the hepatic tissue.

Dans une mise en oeuvre non limitative du dispositif selon l'invention, le dispositif de calcul est construit et agencé pour calculer un score au moyen d'au moins un paramètre supplémentaire corrélé à l'activité inflammatoire. Par exemple, ce paramètre peut être la valeur des transaminases, ALAT, ASAT, les GGT, l'élasticité hépatique ou la viscosité hépatique.In a non-limiting implementation of the device according to the invention, the calculation device is constructed and arranged to calculate a score by means of at least one additional parameter correlated with the inflammatory activity. By example, this parameter can be the value of transaminases, ALAT, ASAT, GGT, hepatic elasticity or hepatic viscosity.

Dans une mise en oeuvre non limitative du dispositif selon l'invention, le dispositif de calcul est construit et agencé pour calculer un score au moyen d'au moins un paramètre supplémentaire corrélé au syndrome métabolique.In a non-limiting implementation of the device according to the invention, the calculation device is constructed and arranged to calculate a score by means of at least one additional parameter correlated with the metabolic syndrome.

Dans une mise en oeuvre non limitative du dispositif selon l'invention, le dispositif de calcul est construit et agencé pour calculer un score au moyen d'au moins un paramètre supplémentaire de type anthropomorphique.In a non-limiting implementation of the device according to the invention, the calculation device is constructed and arranged to calculate a score by means of at least one additional parameter of the anthropomorphic type.

Dans une mise en oeuvre non limitative du dispositif selon l'invention, le dispositif de calcul est construit et agencé pour calculer un score au moyen d'au moins un paramètre supplémentaire de type biologique. Le au moins un paramètre biologique peut par exemple être choisi parmi les paramètres suivants : transaminases(ASAT, ALAT), GGT, PAL, Fer sérique, ferritine, saturation en transférine, adipokine (par exemple, adiponectine, leptine, resistine), cytokine (par exemple, TNFα, IL6, IL1-β), cholestérol HDL, glycémie, insulinémie, bilirubine, a2macroglobuline, haptoglobine, apolipoprotéine A1, CK18, triglycérides, adiponectine, urée, polymorphisme génétique (par exemple : polymorphisme PNPLA3, TM6SF2), CRP et/ou leptine.In a non-limiting implementation of the device according to the invention, the calculation device is constructed and arranged to calculate a score by means of at least one additional parameter of biological type. The at least one biological parameter can for example be chosen from the following parameters: transaminases (ASAT, ALAT), GGT, ALP, serum iron, ferritin, transferrin saturation, adipokine (for example, adiponectin, leptin, resistin), cytokine ( e.g., TNFα, IL6, IL1-β), HDL cholesterol, blood glucose, insulinaemia, bilirubin, a2macroglobulin, haptoglobin, apolipoprotein A1, CK18, triglycerides, adiponectin, urea, genetic polymorphism (e.g. PNPLA3 polymorphism, TM6SF2), CRP and / or leptin.

Dans une mise en oeuvre non limitative du dispositif selon l'invention, le dispositif de calcul est construit et agencé pour communiquer avec un dispositif d'affichage du score. Le score peut être affiché sous la forme d'une valeur numérique, d'un indicateur binaire, une probabilité ou un risque. Ce mode de réalisation présente notamment l'avantage de permettre une simplicité d'interprétation de l'analyse du score reflétant un état d'une liaison hépatique calculée.In a non-limiting implementation of the device according to the invention, the calculation device is constructed and arranged to communicate with a score display device. The score can be displayed as a numerical value, a binary indicator, a probability or a risk. This embodiment has in particular the advantage of allowing simplicity of interpretation of the analysis of the score reflecting a state of a calculated hepatic connection.

Un aspect de l'invention porte également sur un score prenant en compte les paramètres au moins physiques voire biologiques suivants :

  • Un paramètre corrélé à l'inflammation et/ou la fibrose, et
  • Un paramètre corrélé à la stéatose.
One aspect of the invention also relates to a score taking into account the following at least physical or even biological parameters:
  • A parameter correlated with inflammation and/or fibrosis, and
  • A parameter correlated with steatosis.

Dans une réalisation non-limitative, le score prend en compte au moins un paramètre d'activité inflammatoire. Le au moins un paramètre d'activité inflammatoire peut être choisi parmi les paramètres suivants : la valeur des transaminases, l'élasticité hépatique ou la viscosité hépatique.In a non-limiting embodiment, the score takes into account at least one inflammatory activity parameter. The at least one activity parameter inflammation can be chosen from the following parameters: the value of transaminases, hepatic elasticity or hepatic viscosity.

Dans une réalisation non-limitative, le score prend en compte au moins un paramètre anthropomorphique de type poids, taille, tour de taille, tour de hanche, périmètre thoracique ou un paramètre démographique de type âge et sexe.In a non-limiting embodiment, the score takes into account at least one anthropomorphic parameter of the weight, height, waist circumference, hip circumference, thoracic perimeter or demographic parameter of the age and sex type.

Dans une réalisation non-limitative, le score prend en compte au moins paramètre biologique.In a non-limiting embodiment, the score takes into account at least a biological parameter.

Le au moins un paramètre biologique peut être choisi parmi les paramètres suivants : transaminases (ASAT, ALAT), GGT, PAL, Fer sérique, ferritine, saturation en transférine, adipokine (par exemple, adiponectine, leptine, resistine) cytokine (par exemple, TNFα, IL6, IL1-β), cholestérol, cholestérol HDL, glycémie, insulinémie, bilirubine, a2macroglobuline, haptoglobine, apolipoprotéine A1, CK18, triglycérides, adiponectine, urée, polymorphisme génétique (par exemple : polymorphisme PNPLA3, TM6SF2), CRP et/ou leptine.The at least one biological parameter can be chosen from the following parameters: transaminases (ASAT, ALAT), GGT, ALP, serum iron, ferritin, transferrin saturation, adipokine (for example, adiponectin, leptin, resistin) cytokine (for example, TNFα, IL6, IL1-β), cholesterol, HDL cholesterol, blood glucose, insulin, bilirubin, a2macroglobulin, haptoglobin, apolipoprotein A1, CK18, triglycerides, adiponectin, urea, genetic polymorphism (e.g. PNPLA3 polymorphism, TM6SF2), CRP and/ or leptin.

Le paramètre biologique peut être un paramètre métabolomique.The biological parameter can be a metabolomic parameter.

Dans une réalisation non-limitative, le score est calculé au moyen de d'une modélisation statistique (également dénommé apprentissage statistique) de type régression logistique, arbres de décisions, classificateur bayésien, forêts aléatoires, SVM, réseau de neurone, analyse discriminante, etc.In a non-limiting embodiment, the score is calculated using statistical modeling (also called statistical learning) of the logistic regression type, decision trees, Bayesian classifier, random forests, SVM, neural network, discriminant analysis, etc. .

BREVE DESCRIPTION DES FIGURESBRIEF DESCRIPTION OF FIGURES

D'autres caractéristiques et avantages de l'invention ressortiront clairement de la description qui en est donnée ci-après, à titre indicatif et nullement limitatif, en référence :

  • à la figure 1 illustrant, de façon schématique, un premier exemple de réalisation d'un dispositif de calcul d'un score reflétant un état d'une lésion hépatique intégré dans un dispositif construit et agencé pour mesurer l'élasticité hépatique,
  • à la figure 2 illustrant, de façon schématique, un deuxième exemple de réalisation d'un dispositif de calcul d'un score reflétant un état d'une lésion hépatique construit et agencé pour communiquer avec un échographe distant.
Other characteristics and advantages of the invention will emerge clearly from the description which is given hereafter, by way of indication and in no way limiting, with reference:
  • to the figure 1 schematically illustrating a first embodiment of a device for calculating a score reflecting a state of hepatic lesion integrated into a device constructed and arranged to measure hepatic elasticity,
  • to the picture 2 schematically illustrating a second embodiment of a device for calculating a score reflecting a state of liver damage constructed and arranged to communicate with a remote ultrasound scanner.

DESCRIPTION DE L'INVENTIONDESCRIPTION OF THE INVENTION

La figure 1 représente un dispositif 100 de calcul d'un score reflétant un état d'une lésion hépatique intégré dans un dispositif 200 construit et agencé pour mesurer l'élasticité hépatique.There figure 1 represents a device 100 for calculating a score reflecting a state of hepatic damage integrated into a device 200 constructed and arranged to measure hepatic elasticity.

Dans ce mode de réalisation non limitatif, le dispositif 200 comporte une sonde d'élastographie 201 munie d'un transducteur ultrasonore 202 construit et agencé pour émettre et recevoir des ondes ultrasonores. Dans ce mode de réalisation, la sonde d'élastographie 201 comporte en outre des moyens pour générer une onde de cisaillement dans le tissu hépatique. Lesdits moyens peuvent être un actionneur électrodynamique 203 construit et agencé pour générer une onde basse fréquence. Le dispositif 200 est donc construit et agencé pour mesurer des paramètres physiques, par exemple des paramètres qui sont corrélés à l'inflammation et/ou à la fibrose et des paramètres qui sont corrélés à la stéatose.In this non-limiting embodiment, the device 200 comprises an elastography probe 201 equipped with an ultrasonic transducer 202 built and arranged to emit and receive ultrasonic waves. In this embodiment, the elastography probe 201 further comprises means for generating a shear wave in the hepatic tissue. Said means can be an electrodynamic actuator 203 constructed and arranged to generate a low frequency wave. The device 200 is therefore constructed and arranged to measure physical parameters, for example parameters which are correlated with inflammation and/or fibrosis and parameters which are correlated with steatosis.

A titre d'exemple, un paramètre lié à la fibrose peut être l'élasticité du foie. Cette mesure d'élasticité constitue un marqueur de l'état pathologique du tissu hépatique.By way of example, a parameter linked to fibrosis can be the elasticity of the liver. This measure of elasticity constitutes a marker of the pathological state of the liver tissue.

Le paramètre corrélé à la stéatose peut être une mesure de l'atténuation des ondes ultrasonores dans le tissu hépatique. La stéatose hépatique est une accumulation de graisse dans le foie. La mesure de l'atténuation de la propagation des ondes ultrasonores permet donc de quantifier la stéatose.The parameter correlated with steatosis may be a measure of attenuation of ultrasound waves in liver tissue. Fatty liver disease is an accumulation of fat in the liver. The measurement of the attenuation of the propagation of ultrasonic waves therefore makes it possible to quantify the steatosis.

Le dispositif 100 de calcul d'un score reflétant un état d'une lésion hépatique est construit et agencé pour calculer un score au moyen d'un paramètre corrélé à l'inflammation du tissu hépatique et/ou un paramètre corrélé à la fibrose. Dans l'exemple décrit, ces paramètres sont mesurés au moyen de la sonde d'élastographie 201.The device 100 for calculating a score reflecting a state of liver damage is constructed and arranged to calculate a score by means of a parameter correlated to the inflammation of the hepatic tissue and/or a parameter correlated to the fibrosis. In the example described, these parameters are measured by means of the elastography probe 201.

Dans l'exemple illustré, le dispositif 200 comporte également une interface homme-machine 204 construite et agencée pour entrer des paramètres marqueurs du syndrome métabolique utilisés pour le calcul du score.In the example illustrated, the device 200 also comprises a man-machine interface 204 built and arranged to enter marker parameters of the metabolic syndrome used for the calculation of the score.

Ainsi, un opérateur peut entrer, via l'interface homme-machine 204, des paramètres marqueurs du syndrome métabolique. On entend par syndrome métabolique, l'association d'une série de problèmes de santé ayant en commun un mauvais métabolisme corporel, il s'agit d'un regroupement de facteurs de risque plus ou moins liés par une origine, des cibles métaboliques ou des mécanismes communs. Ce groupe de paramètres peut ainsi comporter : le cholestérol HDL, les triglycérides, la glycémie, la tension artérielle, et/ou le tour de taille.Thus, an operator can enter, via the man-machine interface 204, marker parameters of the metabolic syndrome. Metabolic syndrome means the association of a series of health problems having in common a poor body metabolism, it is a group of risk factors more or less linked by an origin, metabolic targets or common mechanisms. This group of parameters may thus include: HDL cholesterol, triglycerides, glycaemia, blood pressure, and/or waist circumference.

Cette interface homme-machine 204 est également construite et agencée pour entrer des paramètres biologiques utilisés pour le calcul du score. Ces paramètres biologiques peuvent être : les transaminases (ALAT, ASAT), GGT, PAL, Fer sérique, cholestérol, cholestérol HDL, glycémie, insulinémie, bilirubine, a2macroglobuline, haptoglobine, apolipoprotéine A1, CK18, triglycérides, adiponectine, et/ou leptine.This man-machine interface 204 is also constructed and arranged to enter biological parameters used for calculating the score. These biological parameters can be: transaminases (ALT, AST), GGT, PAL, serum iron, cholesterol, HDL cholesterol, glycaemia, insulinaemia, bilirubin, a2macroglobulin, haptoglobin, apolipoprotein A1, CK18, triglycerides, adiponectin, and/or leptin.

Cette interface homme-machine 204 est également construite et agencée pour entrer des paramètres anthropomorphiques et démographiques utilisés pour le calcul du score. Ces paramètres démographiques et anthropomorphiques sont par exemple formés par l'âge, le sexe, la taille, le poids, le tour de taille, le tour de hanche ou le périmètre thoracique d'une personne.This man-machine interface 204 is also constructed and arranged to enter anthropomorphic and demographic parameters used for calculating the score. These demographic and anthropomorphic parameters are for example formed by the age, sex, height, weight, waist circumference, hip circumference or chest circumference of a person.

En fonction de ces différents paramètres, le dispositif de calcul 100 calcule un score au moyen d'une régression logistique ou toute autre méthode de scoring, par exemple du type arbres de décisions, classificateur bayésien, forêts aléatoires, arbres de décision séparateurs à vaste marge (SVM), ou encore réseau de neurone.Depending on these different parameters, the calculation device 100 calculates a score by means of a logistic regression or any other scoring method, for example of the decision tree type, Bayesian classifier, random forests, large margin separator decision trees (SVM), or neural network.

A cette fin, le dispositif de calcul 100 peut être formé par un ou plusieurs microprocesseurs construit(s) et adapté(s) pour exécuter des séquences d'instructions permettant une mise en oeuvre de la régression logistiques précitée ou toute autre méthode de scoring.To this end, the calculation device 100 can be formed by one or more microprocessors constructed and adapted to execute sequences of instructions allowing implementation of the aforementioned logistic regression or any other scoring method.

Dans l'exemple illustré, le score calculé est représenté sous la forme d'un indicateur binaire 205 égal à 1 et affiché sur un écran 206 du dispositif 200. Cet indicateur binaire 205 peut être utilisé pour recommander à un patient de réaliser une consultation auprès d'un spécialiste. Par exemple, lorsque l'indicateur est égal à 1, le patient est diagnostiqué comme étant à risque et nécessite une investigation plus poussée ou des examens complémentaires doivent être réalisés.In the example illustrated, the calculated score is represented in the form of a binary indicator 205 equal to 1 and displayed on a screen 206 of the device 200. This binary indicator 205 can be used to recommend that a patient carry out a consultation with from a specialist. For example, when the indicator is equal to 1, the patient is diagnosed as being at risk and requires further investigation or additional tests must be performed.

A contrario, lorsque l'indicateur est égal à 0, le patient ne doit pas consulter de spécialiste. Cet indicateur peut également être différent, il peut être implémenté sous la forme d'une valeur.Conversely, when the indicator is equal to 0, the patient should not consult a specialist. This indicator can also be different, it can be implemented as a value.

Dans cette réalisation non limitative, les mesures de paramètres physiques, l'entrée d'autres paramètres, le calcul du score et l'affichage du score sont réalisés sur le dispositif 200. Ainsi, ce mode de réalisation présente notamment l'avantage de calculer en temps réel le score (autrement dit sur le lieu où sont réalisées les mesures des paramètres physiques), puis d'afficher le score permettant ainsi une rapidité d'analyse.In this non-limiting embodiment, the measurements of physical parameters, the entry of other parameters, the calculation of the score and the display of the score are carried out on the device 200. Thus, this embodiment has in particular the advantage of calculating in real time the score (in other words on the place where the measurements of the physical parameters are carried out), then to display the score thus allowing a speed of analysis.

Dans des exemples différents non limitatifs, le dispositif 200 peut être formé par un échographe, un IRM, ou un IRM mettant en oeuvre l'élastographie par résonance magnétique (MRE).In different non-limiting examples, the device 200 can be formed by an ultrasound scanner, an MRI, or an MRI implementing magnetic resonance elastography (MRE).

Dans une mise en oeuvre non limitative illustrée sur la figure 2, le dispositif de calcul d'un score reflétant un état d'une lésion hépatique 100 est construit et agencé pour communiquer avec un échographe 300 distant. Autrement-dit, le dispositif de calcul 100 est déporté vis-à-vis de l'échographe 300. Ainsi, les mesures sont réalisés sur l'échographe 300 puis transmises par une liaison réseau 140, par exemple une liaison de type Ethernet ou Bluetooth ou Wi-Fi, au dispositif de calcul 100. Il est également possible de transmettre d'autres paramètres, par exemple de type anthropomorphiques ou démographiques, au dispositif de calcul 100 via un ordinateur 400. De façon similaire, cet ordinateur 400 peut communiquer avec le dispositif de calcul 100 via une liaison Ethernet ou Wi-Fi 150. Le dispositif de calcul 100 peut être matérialisé par un ou plusieurs processeurs. Par ailleurs, l'ordinateur peut être intégré dans l'échographe 300.In a non-limiting implementation illustrated in the picture 2 , the device for calculating a score reflecting a state of liver damage 100 is constructed and arranged to communicate with a remote ultrasound scanner 300 . In other words, the computing device 100 is remote from the ultrasound scanner 300. Thus, the measurements are made on the ultrasound scanner 300 then transmitted by a network link 140, for example an Ethernet or Bluetooth type link. or Wi-Fi, to the computing device 100. It is also possible to transmit other parameters, for example of the anthropomorphic or demographic type, to the computing device 100 via a computer 400. Similarly, this computer 400 can communicate with the computing device 100 via an Ethernet or Wi-Fi link 150. The computing device 100 can be materialized by one or more processors. In addition, the computer can be integrated into the 300 ultrasound system.

Dans cette réalisation non limitative, l'affichage du score peut être réalisé sur l'échographe 300, sur l'ordinateur 400 ou les deux.In this non-limiting embodiment, the display of the score can be carried out on the echograph 300, on the computer 400 or both.

Différents aspects de l'invention sont présentés ci-dessous :

  1. A. Dispositif de calcul (100) d'un score (205) pour l'homme ou l'animal ledit score (205) étant une évaluation quantitative ou semi-quantitative d'une lésion hépatique de type stéato-hépatite d'origine alcoolique ou non-alcoolique, ledit dispositif de calcul (100) étant construit et agencé pour calculer un score (205) au moyen des paramètres au moins physiques voire biologiques suivants :
    • Un paramètre corrélé à l'inflammation et/ou à la fibrose,
    • Un paramètre corrélé à la stéatose.
  2. B. Dispositif de calcul (100) selon l'aspect A, le dispositif étant embarqué dans :
    • un échographe, ou
    • un dispositif construit et agencé pour mesurer au moins l'élasticité hépatique.
  3. C. Dispositif de calcul (100) selon l'aspect B, le dispositif étant construit et agencé pour délivrer le score de manière concomitante aux paramètres physiques mesurés.
  4. D. Dispositif de calcul (100) selon l'aspect A, le dispositif étant est construit et agencé pour communiquer avec :
    • un échographe distant, ou
    • un dispositif distant construit et agencé pour mesurer au moins l'élasticité hépatique.
  5. E. Dispositif de calcul (100) selon l'un quelconque des aspects A à D, dans lequel le paramètre corrélé à la fibrose est l'élasticité.
  6. F. Dispositif de calcul (100) selon l'un quelconque des aspects A à E, dans lequel le paramètre corrélé à la stéatose est une mesure de l'atténuation des ondes ultrasonores.
  7. G. Dispositif de calcul (100) selon l'un quelconque des aspects A à F, dans lequel le paramètre corrélé à la stéatose est une mesure de la viscosité hépatique.
  8. H. Dispositif de calcul (100) selon l'un quelconque des aspects A à G, le dispositif étant construit et agencé pour calculer un score au moyen d'au moins un paramètre supplémentaire corrélé à l'activité inflammatoire.
  9. I. Dispositif de calcul (100) selon l'aspect H, dans lequel le paramètre supplémentaire corrélé à l'activité inflammatoire est choisi parmi : ALAT, ASAT, les GGT, l'élasticité hépatique et la viscosité hépatique.
  10. J. Dispositif de calcul (100) selon l'un quelconque des aspects A à I, le dispositif étant construit et agencé pour calculer un score au moyen d'au moins un paramètre supplémentaire corrélé au syndrome métabolique.
  11. K. Dispositif de calcul (100) selon l'un quelconque des aspects A à J, le dispositif étant construit et agencé pour calculer un score au moyen d'au moins un paramètre supplémentaire de type anthropomorphique.
  12. L. Dispositif de calcul (100) selon l'un quelconque des aspects A à K, le dispositif étant construit et agencé pour calculer un score au moyen d'au moins un paramètre supplémentaire de type biologique.
  13. M. Dispositif de calcul (100) selon l'un quelconque des aspects A à L, le dispositif étant construit et agencé pour communiquer avec un dispositif d'affichage (206) du score (205).
  14. N. Dispositif de calcul (100) selon l'aspect M, dans lequel le score (205) est affiché sous la forme d'une valeur numérique, d'un indicateur binaire, une probabilité ou un risque
Different aspects of the invention are presented below:
  1. A. Device (100) for calculating a score (205) for humans or animals, said score (205) being a quantitative or semi-quantitative evaluation of a hepatic lesion of the steatohepatitis type of alcoholic origin or non-alcoholic, said calculation device (100) being constructed and arranged to calculate a score (205) by means of the following at least physical or even biological parameters:
    • A parameter correlated with inflammation and/or fibrosis,
    • A parameter correlated with steatosis.
  2. B. Computing device (100) according to aspect A, the device being embedded in:
    • an ultrasound machine, or
    • a device constructed and arranged to measure at least hepatic stiffness.
  3. C. Computing device (100) according to aspect B, the device being constructed and arranged to deliver the score concomitantly with the measured physical parameters.
  4. D. Computing device (100) according to aspect A, the device being is constructed and arranged to communicate with:
    • a remote ultrasound system, or
    • a remote device constructed and arranged to measure at least hepatic stiffness.
  5. E. A computing device (100) according to any of aspects A through D, wherein the parameter correlated to fibrosis is elasticity.
  6. F. A computing device (100) according to any of aspects A through E, wherein the steatosis-correlated parameter is a measure of ultrasound wave attenuation.
  7. G. A computing device (100) according to any of aspects A through F, wherein the parameter correlated to steatosis is a measure of liver viscosity.
  8. H. Calculating device (100) according to any one of aspects A to G, the device being constructed and arranged to calculate a score using at least one additional parameter correlated with inflammatory activity.
  9. I. Calculation device (100) according to aspect H, in which the additional parameter correlated with the inflammatory activity is chosen from: ALT, AST, the GGTs, the hepatic elasticity and the hepatic viscosity.
  10. J. Calculating device (100) according to any one of aspects A to I, the device being constructed and arranged to calculate a score using at least one additional parameter correlated to the metabolic syndrome.
  11. K. Computing device (100) according to any one of aspects A to J, the device being constructed and arranged to calculate a score using at least one additional parameter of the anthropomorphic type.
  12. L. Computing device (100) according to any one of aspects A to K, the device being constructed and arranged to calculate a score using at least one additional biological type parameter.
  13. M. Computing device (100) according to any one of aspects A to L, the device being constructed and arranged to communicate with a display device (206) of the score (205).
  14. N. Computing device (100) according to aspect M, in which the score (205) is displayed as a numerical value, a binary indicator, a probability or a risk

Claims (9)

Dispositif de calcul (100) d'un score (205) pour l'homme ou l'animal, ledit score (205) étant une évaluation quantitative ou semi-quantitative d'une lésion hépatique de type stéato-hépatite d'origine alcoolique ou non-alcoolique, le score étant calculé au moyen d'une modélisation statistique, le score étant fonction des paramètres physiques et biologiques suivants : - Un paramètre corrélé à la fibrose ; - Un paramètre corrélé à la stéatose ; et - Un paramètre corrélé à l'activité inflammatoire ; dans lequel le paramètre corrélé à la fibrose est l'élasticité hépatique ; dans lequel le paramètre corrélé à la stéatose est une mesure d'atténuation des ondes ultrasonores ou une mesure de viscosité hépatique ; dans lequel le paramètre corrélé à l'activité inflammatoire est un paramètre parmi : ALAT, ASAT et GGT. Device for calculating (100) a score (205) for humans or animals, said score (205) being a quantitative or semi-quantitative evaluation of a hepatic lesion of the steatohepatitis type of alcoholic or non-alcoholic, the score being calculated by means of statistical modelling, the score being a function of the following physical and biological parameters: - A parameter correlated with fibrosis; - A parameter correlated with steatosis; And - A parameter correlated with inflammatory activity; in which the parameter correlated with the fibrosis is the hepatic elasticity; wherein the parameter correlated to the steatosis is a measure of attenuation of the ultrasonic waves or a measure of hepatic viscosity; wherein the parameter correlated to the inflammatory activity is one of: ALAT, ASAT and GGT. Dispositif de calcul (100) selon la revendication 1, dans lequel la modélisation statistique est une régression logistique, un arbre de décision, un classificateur bayésien, ou un réseau de neurones.A computing device (100) according to claim 1, wherein the statistical modeling is logistic regression, decision tree, Bayesian classifier, or neural network. Dispositif de calcul (100) selon l'une des revendications précédentes, caractérisé en ce qu'il est embarqué dans : - un échographe, ou - un dispositif construit et agencé pour mesurer au moins l'élasticité hépatique. Computing device (100) according to one of the preceding claims, characterized in that it is embedded in: - an ultrasound machine, or - a device constructed and arranged to measure at least hepatic elasticity. Dispositif de calcul (100) selon l'une des revendications 1 et 2, caractérisé en ce qu'il est construit et agencé pour communiquer avec : - un échographe, ou - un dispositif construit et agencé pour mesurer au moins l'élasticité hépatique. Computing device (100) according to one of Claims 1 and 2, characterized in that it is constructed and arranged to communicate with: - an ultrasound machine, or - a device constructed and arranged to measure at least hepatic elasticity. Dispositif de calcul (100) selon l'une quelconque des revendications précédentes, caractérisé en ce qu'il est construit et agencé pour calculer un score au moyen d'au moins un paramètre supplémentaire corrélé au syndrome métabolique.Calculation device (100) according to any one of the preceding claims, characterized in that it is constructed and arranged to calculate a score by means of at least one additional parameter correlated with the metabolic syndrome. Dispositif de calcul (100) selon l'une quelconque des revendications précédentes caractérisé en ce qu'il est construit et agencé pour calculer un score au moyen d'au moins un paramètre supplémentaire de type anthropomorphique.Calculation device (100) according to any one of the preceding claims , characterized in that it is constructed and arranged to calculate a score by means of at least one additional parameter of the anthropomorphic type. Dispositif de calcul (100) selon l'une quelconque des revendications précédentes caractérisé en ce qu'il est construit et agencé pour calculer un score au moyen d'au moins un paramètre supplémentaire de type biologique.Calculation device (100) according to any one of the preceding claims , characterized in that it is constructed and arranged to calculate a score by means of at least one additional parameter of biological type. Dispositif de calcul (100) selon l'une quelconque des revendications précédentes caractérisé en ce qu'il est construit et agencé pour communiquer avec un dispositif d'affichage (206) du score (205).Calculation device (100) according to any one of the preceding claims , characterized in that it is constructed and arranged to communicate with a display device (206) of the score (205). Dispositif de calcul (100) selon la revendication précédente caractérisé en ce que le score (205) est affiché sous la forme d'une valeur numérique, d'un indicateur binaire, une probabilité ou un risque.Calculation device (100) according to the preceding claim , characterized in that the score (205) is displayed in the form of a numerical value, a binary indicator, a probability or a risk.
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